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Trainer Notes: Present the session learning objectives. Reader Notes: This session aims to provide knowledge and skills to care for women living with HIV, with special emphasis on intervention to prevent mother to child transmission of HIV infection. You will have the opportunity to understand the risk factors involved in transmission and the challenges in preventing perinatal infection. PTCT- parent-to-child transmission is known as vertical or perinatal transmission. In most other countries this is referred to as MTCT (mother-to-child-transmission). There are proven interventions to reduce the likelihood of PTCT.

Step 2: Parent to Child Transmission in India (Slide 3-4) - 3 minutes Trainer Notes: The above slide reflects the various routes of transmission in our country. The trainer here needs to stress that the primary drivers of HIV epidemic in India are unprotected paid sex/commercial female sex work, unprotected sex between men and injecting drug use and explain the definition of High risk groups (STD,IDU,MSM,FSW) High risk groups: Female sex workers, IV Drug Users, Truck drivers, Men having sex with men, Sexually Transmitted Diseases and others are included in the high risk category. It is estimated that there are 12.6 lakh Female Sex Workers (FSW), 3.5 lakh Men who have Sex with Men (MSM) with high risk and 1.9 lakh Injecting Drug Users (IDU) in India. Though sex workers account for 0.5 percent of adult female population, they account for seven percent of HIV infected females. Sex work continues to act as the most important source of HIV infections in India due to the large size of clients that get infected from sex workers. Heterosexual mode of transmission is still the predominant mode of HIV transmission in India. Ref: National AIDS Control Organisation (Department of AIDS Control Ministry of Health &amp; Family Welfare Government of India): Annual Report 2009-2010.

Trainer Notes: The trainer may present the data on the slide. Reader Notes: Provisional estimates show that there are 22.7 lakh People living with HIV in India by the end of 2008 with an estimated adult HIV prevalence of 0.29 percent. According to India’s National AIDS Control Organisation (NACO), the bulk of HIV infections in India occur during unprotected heterosexual intercourse. Consequently, and as the epidemic has matured, women account for a growing proportion of people living with HIV (38 percent in 2005), especially in rural areas. Even the HIV prevalence among pregnant women in the age group of 15-24 years, which is considered proxy for incidence/new infections in general population, is showing a declining trend. Source: 1. Annual Report 2009-10 2. The World Bank (2008) &apos;State of the epidemic: India’ http://web.worldbank.org/WBSITE/EXTERNAL/EXTABOUTUS/EXTWEBARCHIVES/0,MDK:22202673~menuPK:64654237~pagePK:64660187~piPK:64660385~theSitePK:2564958,00.html

Step 3: NACO’s Four-Pronged Strategy (Slide 5) - 2 minutes Trainer Notes: The trainer has to explain the four pronged PPTCT strategy of NACO. Reader Notes: NACO has a four-pronged strategy for the PPTCT . The first, primary prevention focuses on preventing HIV among women and men of childbearing age. This can only be achieved as part of a general population-based HIV prevention strategy as discussed in the epidemiology module. Some components of the primary prevention include: Promoting condoms through social marketing and community-based distribution system. This strategy has helped in increasing the use of condoms in the country at large. There is greater need to ensure availability of condoms at places (hospitals and clinics) and times where they are needed. Behaviour change communication (BCC) and social mobilisation campaigns . While there is general awareness about the disease, people are still ignorant on specific aspects like mode of transmission, method of protecting oneself from getting infected. There is an urgent need to generate appropriate programmes which stress interpersonal communication for targeted groups (e.g. students, youth, women, migrant workers and children). Prevention, diagnosis, and treatment of sexually transmitted infections (STIs). The presence of STDs, especially with ulcers or discharge, facilitates transmission of HIV infection. The risk of transmission is 8 to 10 times higher in case of persons having STDs compared with others. Two approaches for STD control adopted by the government are: incorporate management of STDs through Syndromic approach into the general health service and the integrate services for treatment of reproductive tract infections (RTIs) and sexually transmitted infections (STIs) at all levels of health care. The second strategy involves preventing unwanted pregnancies in HIV infected women. This strategy requires provision of VCT services and voluntary, safe, and effective contraception, sterilisation, or abortion. HIV positive women should have complete choice in making decisions regarding pregnancy and childbirth. Proper counselling should be provided to women to enable her to make an appropriate decision either to continue the pregnancy or terminate the pregnancy. The third strategy is to promote interventions to prevent PTCT by HIV-positive mothers . PPTCT programme can reduce the risk of transmission from the mother to the child. Examples include: Comprehensive maternal and child health services (antenatal, postnatal, and child health), voluntary, confidential counselling and testing (VCT), antiretroviral (ARV) prophylaxis, counselling and support for safe infant feeding and optimal obstetrical practices. The fourth strategy is to follow up the positive women and her infant and continue to provide care and support to both. The exposed infant need to be started on CTZ prophylaxis as early as 4-6 weeks for all exposed infants. All immunisations should be considered for these exposed children. The mother needs to be followed up closely and assessment of her eligibility for ART initiation should be done as appropriate if she is not already on ART.

Step 4: Factors Influencing Transmission and Strategies to Reduce Transmission Risk (Slides 6-18) – 22 minutes Trainer Notes: The trainer needs to explain the risk of HIV transmission that exists at each stage of pregnancy. The slide shows the % risk at each stage of pregnancy e.g., antenatal period, labour and delivery period and breastfeeding period. The slide also shows the direct association between duration of breastfeeding and risk of transmission. Reader Notes: Rates vary because of differences in population characteristics such as maternal CD4+ cell counts, RNA viral load and duration of breastfeeding. In the absence of any interventions, HIV transmission from the mother to child is likely to be about 15-45%. Transmission occurs during the Intrapartum period, through contact and ingestion of infected maternal secretions and maternal blood and foetal maternal micro transfusion in labour. Transmission also occurs antenatal due to trans-placental infection and post partum due to infant feeding practices. Source: World Health Organisation. HIV transmission through breastfeeding. A review of available evidence. 2004. Available at http://www.who.int/child-adolescent-health/ publications/Nutrition/ISBN_92_4_156271_4.htm. (Table adapted from De Cock KM et al. Prevention of mother-to-child HIV transmission in resource-poor countries: Translating research into policy and practice. JAMA. 2000 Mar 1; 283(9): 1175-82).

Trainer Notes: Ask the participants to consider the question on the slide. After the discussion review the following slides. If participants are knowledgeable on above information, let them know the following slides are a short review and move through the slides more quickly.

Trainer Notes: The above slide discusses the antenatal factors influencing transmission. Explain each of the points to the participants and ask them to justify the reason for each of the points and facilitate a discussion among the participants. Reader Notes: There is a correlation between the maternal blood viral loads and the risk of transmission. There is no lower limit of viral load, below which there is absolute safety and there is no upper limit above which there will be definite HIV transmission. Studies have shown that the viral load, the phenotype and genotype of the virus found in the plasma may be different from what is present in cervicovaginal secretion. Other factors like viral resistance to Nevirapine may also influence transmission. The lower the CD4 count, the greater risk of transmission. Women who are recently infected and those in clinical stage 3 &amp; 4 have high viremia. Their infants are at higher risk of acquiring the infection. Any infection that induces the presence of immune mediators influences transmission. Sexually transmitted infections in the mother increases genital viral shedding. While pregnancy does not appear to hasten HIV progression, it is clearly an important additional stress on the body above and beyond the effects of HIV and OI, and ARV side effects. Data on the impact of HIV and pregnancy are difficult to interpret, as so many factors may affect the outcome. Most pregnancy complications appear to be related to advanced HIV disease. .

Trainer Notes: Ask participants: Consider invasive delivery techniques? Identify “breaks” in the integrity of the skin. Answer: This is not dissimilar to women or men with genital ulcers. In this case, it is strictly accessed by the virus to the infant’s blood. Infant will be exposed to vaginal fluids containing HIV. If there is haemorrhage, infant will be exposed to mother’s blood with HIV. If there is an episiotomy, infant will be exposed to mother’s blood with HIV. If there is invasive foetal monitoring, the skin integrity of the infant is altered, allowing a portal for infection. Unless the mother’s viral load is suppressed, HIV transmission to baby is generally higher with vaginal delivery than C-section if C-section is performed before labour and rupture of membranes. However, maternal mortality, cost, and skill level is so much higher than vaginal delivery, that C-section is often impractical in many settings in India.

Trainer Notes: Ask participants the following questions: Question 1: Why would a premature baby be at higher risk than a full term infant? Answers: Encourage participants to think about the biggest organ of the immune system: skin. Remind people how the skin looks like in a premature baby –fragile, porous. Question 2: How can low birth weight be a risk factor? Answers: Low birth weight could mean lower resistance and therefore increased risk to HIV. Question 3: What about first infant? Usually we consider twin A to be healthier and often larger. Answers: Twin A is first in the birth canal, exposed to maternal fluids, bearing “brunt” of contractions. Twin B, smaller, usually slips right through the “cleaned” birth canal in minutes rather than hours. Question 4: What about immature GI tract? Answers: Again, think of the newborn with fragile GI tract mucus membrane that may have swallowed infected vaginal secretions and/or amniotic fluid that has been exposed to HIV-infected vaginal secretions.

Trainer Notes: Ask participants the following questions: Question 1: Why does becoming infected with HIV while breastfeeding increases the risk of transmission? Answer: With recent infection there is increased viral load (it will take 6-24 weeks for the body to make antibody to control the virus). The viral load may be in the millions, and transmission risk is increased. Question 2: What about “Mixed” feeding? Answer: Microscopic bleeds in baby’s gut could occur from foods other than breast milk (e.g. kanji (porridge), cow’s milk, etc) This, when followed by ingestion of infected breast milk by the baby, increases its risk of acquiring HIV. Question 3: What about breast pathologies, like cracked nipples? Answer: It increases the risk as both breast milk and blood may be swallowed by the baby. Question 4: What interventions would you discuss with mother in the event of mastitis or bleeding nipples? Answer: Preferable to express breast milk and heat it slightly. This could kill the virus. Avoid feeding from the affected breast if possible. Avoid mixed feeding. Advanced disease in the mother, poor nutrition could increase the risk of transmission. Prolonged breast feeding increases the risk of HIV transmission. Question 5: Would sores in the baby’s mouth increase the risk? Answer: Yes, since the virus could have direct access to the baby’s blood vessels through the cuts. Reader Notes: The factor conferring the greatest risk is the mother becoming infected herself during pregnancy or lactation. Advantages of exclusive breast feeding over mixed feeding need to be emphasised during infant feeding counselling sessions. When replacement feeding (infant formula) is acceptable, feasible, affordable, sustainable and clean water is available, then only the HIV-infected mothers should avoid breastfeeding completely. Conditions to consider during feeding options counselling: Home environment refers to resources such as refrigerators, cooking facilities, fuel, electricity, etc. For example, difficulty in boiling water 8 times a day or safe storage of milk. Education on how to manage breastfeeding or prepare breast milk substitute and the importance of not mixing the feeds. Income refers to capacity to buy supplies, or taking break during work to breastfeed. Do they have resources to boil water, type of contamination during transport and to store water safely? It may also be difficult to get water. Family and community support is very important for successful feeding of the child. Breastfeeding support groups and health worker support also play a role. Time available for child care is important. If the mother is working, who takes care of child for exclusive breastfeeding/ preparing and feeding of replacement milk? Access to counselling is especially important during the management of breastfeeding problems or artificial feeding problems.

Trainer Notes: The trainer can explain the interventions during pregnancy that can control the transmission risk. Reader Notes: Primary prevention includes: Education about safe sex with use of condoms for mother AND father. Early treatment of STIs. Encouraging safe sex during pregnancy and lactation. Physicians should provide similar care to HIV-positive women as for HIV-negative women. They should have the same number of antenatal visits. Antenatal visits are vital opportunities for PPTCT for both HIV-positive and HIV-negative women. Whether positive or negative, all women should recognise the risk of initial infection, super-infection if they are already infected and STIs in terms of increased burden on the immune system. Pregnancy is not necessarily high risk in HIV-positive women. Invasive antenatal test and procedures must be avoided and voluntary counselling and testing (VCT) to be given all pregnant women. The eventual goal is no mother-to-child transmission. While this may not be possible currently, we can greatly reduce transmission by using the practices described in this unit.

Trainer Notes: The trainer should explain that vaginal examinations need to be minimised so that infection can be prevented. Long duration of rupture of membranes increase the transmission risk. It has been estimated that with every hour, the risk of transmission increases by 2%. Studies have shown that uterine manipulations like amniocentesis and external cephalic version increase the risk of transmission of HIV. Placental disruption and infections also adversely affect transmission. Invasive foetal monitoring should be avoided, as should all invasive obstetric procedures.

Trainer Notes: The trainer should explain the interventions that need to be done during labour and delivery to minimise transmission risk. Any procedure that makes mother’s blood in contact with foetus is to be avoided. The suction should not be used unless absolutely necessary. Before moving to the next slide the trainer may pose the question “ what is the ideal mode of delivery that can minimise transmission” Answers: Where facilities are available, elective LSCS should be offered. This will most likely minimise the risk of transmission as against any other mode of delivery. Where not feasible, obstetricians should learn safer ways to deliver babies of HIV positive women. If instrumental delivery is necessary, then forceps are a better option than vacuum suction cup delivery. Emergency LSCS is associated with high transmission of mother to child transmission.

Reader Notes: Delivery can be an emotional time for pregnant women. It could be even more so for women who have fears about disclosure, confidentiality, and transmission of HIV to the baby. The staff must be extremely sensitive and respectful in making these stressful situations less traumatic for the mother and her family. General practice recommends that an elective C-section is NOT considered a standard PPTCT intervention. Benefits of protecting the baby from HIV are better understood than risk to mothers (i.e., infection, wound dehiscence) and risk to the health-care workers. It is a complex issue that must be discussed. Clinical judgment and the mother’s wishes should guide the decision. It is indicated and effective in certain clinical situations such as when the viral load of mother is extremely high, and should be done before onset of labour preferably at 38 weeks and electively based on mothers wishes and facilities available, but is not standard practice. In India – normal delivery is recommended unless the woman has obstetric reasons (like foetal distress, obstructed labour, etc) for a C-section. Use of ART can reduce risk of PTCT better and with less risk than a C-section.

Trainer Notes: Ask participants the following questions: Question 1: What are signs and symptoms of HIV infection in the infant? Answer: Fever Failure to gain weight (may suggest HIV and/or malnutrition) Lymphadenopathy Loss of milestones Hepatosplenomegaly Recurrent/recalcitrant infections Otitis media Candidiasis (Most infants have thrush, so this is not a reliable indicator of HIV infection) Parotid enlargement Question 2: What are other interventions and care issues for a baby born to an HIV positive mother? Answer: Infants exposed to HIV should start cotrimoxazole at 4 weeks (starting earlier may interfere with bilirubin conjugation). Cotrimoxazole is continued until the baby is one year old or till the baby is detected as uninfected. Infants who may be HIV infected are at high risk of acquiring PCP. Cotrimoxazole prevents PCP, which has the highest morbidity and mortality for children with HIV. The highest incidence is 3 to 6 months of age, before the baby is accurately diagnosed. Give all standard immunisations as per schedule. Sick children born to an HIV-positive mother should be evaluated immediately for diagnosis and treatment. Diagnosis difficult because maternal antibodies cross placenta. Perform HIV-antibody test at 18 months. HIV DNA PCR (viral load) is more accurate in newborns. If baby is HIV negative, discontinue cotrimoxazole PCP prophylaxis. Carefully monitor and document care. Infant is considered indeterminate status until 15-18 months. If HIV-DNA PCR is available: A positive test at 6-12 weeks of age means infection. A negative test 6 weeks after stopping breastfeeding means infection very unlikely. The goal is to diagnose babies who are HIV positive in order to provide timely treatment. Refer participants to Handout 2 for testing algorithm in a HIV -1 exposed infant as per current NACO guidelines

Trainer Notes: Three options that could be told to the mother about feeding the baby: No breast feeding at all (Exclusive Artificial Feeds) Breast feeding exclusively (no other feeds, not even water) till 4 months and then stop abruptly and move to other milk. Breast feeding for 6 months exclusively and then stop abruptly and move to weaning foods. Duration of breast feeding: Longer the duration of the breast feeding, the higher the risk of HIV transmission. If this factor were to be considered, then the first option is better than the second option and the second is better than the third option. However considering the Indian situation (poor hygienic practices, ignorance of mother, lack of resources to buy materials for feeding, etc.) the chance of baby dying due to gastroenteritis is higher than the chance of the child dying of HIV. If this were to be considered then the second option is better than the third and is better than the first option. Reader Notes: The highest risk of HIV transmission during lactation occurs in women who acquire HIV while breastfeeding. When replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breastfeeding by HIV-infected mothers is recommended. Exclusive Breastfeeding: infant is given ONLY breast milk, no other liquids or foods. Baby is NEVER given anything else to drink — not even water. Exclusive breastfeeding is recommended during the first months of life, with early abrupt weaning at 3-4 months or 6 months of age. If breastfeeding exclusively, minimise HIV risk to baby through the following: Use only breast milk for the period. Not even water, tea, or liquid diet to be given. Infants weaned before 6 months needs alternative feeding with formula - use a cup to feed, not bottle with nipple, for hygiene purposes. Refer to handout 3 for the latest Indian guidelines on Infant Feeding in HIV positive mothers

Trainer Notes: The trainer should use a pointer to explain the graph Readers notes: In this study where 551 children born to HIV positive mothers were followed up over a period of time the mixed fed infants (as shown by the red line) had more probability of becoming sero-positive as compared to children who were exclusively breast fed (light blue dotted lines) or never breast fed (dark blue dotted lines).This shows that mixed feeding should not be given for infants born to HIV positive mothers. Exclusive breastfeeding and replacement feeding had similar risk of seroconversion among infants. Therefore in many resource limited countries exclusive breastfeeding is practiced and is a cheaper option available. Source: BMJ Volume 322, 3 March 2001: bmj.com Further detailed about breast feeding options will be discussed in the next session.

Step 5: ARV Interventions to Decrease Parent-to-Child Transmission (PTCT) (Slides 19-28) - 18 minutes Trainer Notes: The trainer should ask the following questions to the participants- What does ARV therapy and ARV prophylaxis mean? ARV therapy means providing antiretroviral drugs for the treatment of maternal HIV infection while ARV prophylaxis is provision of antiretroviral chemoprophylaxis to reduce the risk of perinatal HIV transmission. What is the difference between the two terms? Through ARV therapy, the mother’s infection is being treated and she is benefitted by this treatment whereas through ARV prophylaxis only the transmission risk to the child is addressed and the maternal infection is not treated. What does these terms imply in terms of clinical practice? If the mother is eligible for ARV therapy to treat her own infection as well as reduce the perinatal transmission then the treating physician should start her on ART as per the national guidelines for initiating ART for pregnant women. If the Mother is not eligible to initiate ART as per the NACO guidelines then she must receive ARV prophylaxis.

Trainer Notes: Adequate and appropriate ARV prophylaxis, safe methods of delivery and good care of the mother during the antenatal period will help to decrease risk of transmission. This is a review of ARV interventions that summarise efforts to decrease the risk to babies. Our goal is to prevent the HIV transmission. ARV’s require ongoing care and monitoring and reduce risk of PTCT in the following ways: Reduces viral replication and viral load. Treats maternal infection. Protects the HIV-exposed infant. Improves overall health of mother. Advantages of ART during pregnancy: Antiretroviral therapy reduces risk of transmission even in mothers with low baseline viral loads. Combination therapy with 3 drugs-ART can reduce transmission risk to &lt;2% in many cases. Combination ART is the best way to prevent PTCT. Remember that in developed countries vertical transmission rarely happens, especially for women on ART (less than 70 nationwide in the U.S., 2003). ARV’s are safe, well tolerated and easy to use in a pregnant woman who is carefully monitored. It is economical because it eliminates the need for the HIV care and treatment of infected babies (there will not be any, or they will be a few in number). Reduces the risk of the mother developing resistance, thereby preserving her future treatment options. GOI guidelines for PPTCT include single dose of Nevirapine for all pregnant positive women. Risks to infant (teratogenicity, preterm labour) appear to be minimal for most regimens. EFV has a teratogenic effect and is contraindicated in pregnancy. It should be avoided in women of child-bearing age who are not on effective contraceptives.

Trainer Notes: Trainer has to discuss the contents of the slide and to explain, why there is a need to revise the current guidelines ARV drugs decrease the viral load and thus decrease the transmission rates. Single dose NVP 200mg given at the onset of labour and single dose of syrup NVP 2mg/kg weight to the baby within 72 hours decreases risk of transmission by 13.1% (breast feeding). Advantages: Affordable, single dose easy administration, appropriate for resource poor settings. Disadvantages: Resistance even with single dose of NVP, which makes it difficult to treat mother if she needs ART for her own health in the near future. Baby may get infected with NVP resistant strains. If the women delivers within 2 hours of administering NVP, the baby needs syrup NVP 2mg/kg soon after delivery and a second dose at 72 hours of age. If a women gets NVP and the labour turns out be false labour, there is need to repeat NVP only if does not deliver in the next seven days. Studies have proved beyond doubt that AZT is most effective pre exposure prophylaxis for the baby. The drug is metabolised into its active form in the placenta and the mother to child drug concentration is also high. The first study PACTG 076 demonstrated starting AZT from 14 weeks, and the Thai studies started at 28 weeks and 36 weeks, which have proved very effective in preventing transmission in women that choose to breast feed as well as non breast feeding women. Transmission rates 8.3 %, 6.5%, 8.6 % (non breastfeeding). Reader Notes: ARV drugs decrease the viral load and thus decrease the transmission rates. Single dose NVP 200mg given at the onset of labour and single dose of syrup NVP 2mg/kg weight to the baby within 72 hours decreases risk of transmission by 13.1% (breast feeding). Advantages: Affordable, single dose easy administration, appropriate for resource poor settings. Disadvantages: Resistance even with single dose of NVP, which makes it difficult to treat mother if she needs ART for her own health in the near future. Baby may get infected with NVP resistant strains. If the women delivers within 2 hours of administering NVP, the baby needs syrup NVP 2mg/kg soon after delivery and a second dose at 72 hours of age. If a women gets NVP and the labour turns out be false labour, there is need to repeat NVP only if does not deliver in the next seven days.

Trainer Notes: The trainer has to explain if the patient is eligible for ART initiation then ART has to be started. If the patient’s CD4 is high and she is NOT considered eligible for ART initiation, then she can go for ARV prophylaxis with single dose Nevirapine. Nevirapine has to be given at the onset of true labour pains – 200mg tab – single dose. Labour pain need to be assessed if it is true labour pains before taking the Nevirapine tablet to avoid Nevirapine resistance. Reader Notes: Advantages of ART during pregnancy: Antiretroviral therapy reduces risk of transmission even in mothers with low baseline viral loads. Combination therapy with 3 drugs-ART can reduce transmission risk to &lt;2% in many cases. Combination ART is the best way to prevent PTCT. Remember that in developed countries vertical transmission rarely happens, especially for women on ART (less than 70 nationwide in the U.S., 2003). ARV’s are safe, well tolerated and easy to use in a pregnant woman who is carefully monitored. It is economical because it eliminates the need for the HIV care and treatment of infected babies (there won’t be any, or they will be few in number). Reduces the risk of the mother developing resistance, thereby preserving her future treatment options. GOI guidelines for PPTCT include single dose of Nevirapine for all pregnant positive women. Risks to infant (teratogenicity, preterm labour) appear to be minimal for most regimens. EFV has a teratogenic effect and is contraindicated in pregnancy. It should be avoided in women of child-bearing age who are not on effective contraceptives.

Trainer Notes: The trainer should ask the participant the discussion question. The answers given can be discussed by the trainer. Answer: Resistance can occur even with single dose of Nevirapine, which makes it difficult to treat mother subsequently if she needs ART for her own health in the immediate future with a NVP based combination ART regimen. Baby may get infected with Nevirapine resistant strains.

Trainer Notes: Antiretroviral therapy in pregnant women has the following advantages: Improves the health of women Decreases the risk of transmitting HIV to infant Pregnant women who are HIV-infected and who are eligible for antiretroviral (ARV) therapy should receive treatment according to national guidelines for initiation of ART in pregnant women ARV is provided by PPTCT programme or the nearest ART centre When to start ARVs is based on symptoms of HIV infection and, where available, laboratory test results. The trainer has to discuss the new NACO guidelines for initiation of ART in pregnant women depending on the availability of CD4 count and or clinical symptoms. It is the same as in adults and adolescents except that EFV cannot be used in the first trimester. The guideline is as shown in the above slide.

Trainer Notes: The first choice for an ART regimen is an AZT based regimen. Decisions should be individualised based on the following factors : Gestational age of the pregnancy Antiretroviral treatment recommendations for the health of the HIV-infected woman The efficacy of antiretroviral regimens for prevention of perinatal HIV transmission Known, suspected, and in some cases unknown effects of particular drugs or regimens on the foetus and newborn, on the outcome of pregnancy, and for the woman Co infections and other drugs used during the pregnancy. Continue to take ARV therapy throughout pregnancy, labour, delivery and postpartum. Ask the following question to the participants” what happens if a patient who is on ARV therapy on a EFV based regimen becomes pregnant.” Answers: If a woman is on Efavirenz (EFV) as a part of her ARV therapy and becomes pregnant: Substitute NVP for EFV if pregnancy if recognised during first trimester. Continue EFV if recognised during second or third trimester

Trainer Notes: The trainer may ask the participants question and discuss the responses with the participants. Answer: Yes, if it has been more than 12 months since the woman received the sd-NVP. Prior exposure to single-dose NVP was associated with an increased risk of treatment failure; however, this risk seems largely confined to women with a more recent exposure. Women requiring ART within 12 months of NVP exposure should not be prescribed an NNRTI-containing regimen as first-line therapy. It is now evident that the risk of intrapartum NVP compromising a mother’s future response to an NNRTI containing regimen is confined mostly to women in whom ART will be needed within 12–15 mo of delivery. Where CD4 + testing is routinely available, programs could minimise the number of women who fall into this risk group by increasing the CD4 + threshold for starting ART in pregnancy to 350 cells/ml, as recommended in the 2006 WHO guidelines . The benefit of this approach would be 2-fold. First, it would ensure that most women exposed to single-dose NVP would not need therapy for at least a year. Second, through the provision of suppressive therapy to precisely those women at highest transmission risk, it would prevent more perinatal HIV infections In the occasional circumstance where a woman did need therapy soon after single dose NVP exposure, a protease inhibitor-containing regimen or a triple nucleoside regimen could be prescribed. Source: Stringer JS, McConnell MS, Kiarie J, Bolu O, Anekthananon T, Jariyasethpong T, Potter D, Mutsotso W, Borkowf CB, Mbori-Ngacha D, Muiruri P, Ong&apos;ech JO, Zulu I, Njobvu L, Jetsawang B, Pathak S, Bulterys M, Shaffer N, Weidle PJ. Effectiveness of non-nucleoside reverse-transcriptase inhibitor-based antiretroviral therapy in women previously exposed to a single intrapartum dose of Nevirapine: a multi-country, prospective cohort study. PLoS Med. 2010 Feb 16;7(2):e1000233

Trainer Notes: The trainer may summarise the key principles of NACO with regard to PPTCT using the points described on the slide.

Trainer Notes: The trainer may summarise the key principles of NACO with regard to PPTCT using the points described on the slide.

Step 6: Case Studies (Slides 29-31) - 9 minutes Trainer Notes: Break participants up into small groups (no more than 4 per group). Ask them to consider the above case and questions for 3 minutes. Solicit answers from the groups. Add any other answers they may have overlooked. Answers: Since all pregnant HIV positive mothers are eligible for CD4 cell count testing at ART centres, this 25 year old pregnant lady has to referred for CD4 cell testing. Based on the CD4 cell count and the WHO Clinical Staging, her management can be planned. If the CD4 cell count is &gt;350 cells/cu.mm, she needs PPTCT prophylaxis (single dose Nevirapine at the time of labour). Other services needed: Post-test counselling. Partner counselling and testing. Couples counselling. Feeding options counselling. Family planning counselling. Selection of a contraception method either permanent/temporary + barrier methods. Regular medical follow up visits of the baby and the mother. HIV testing for the baby at 18 months. Social, economic, mental &amp; spiritual support to the couple and the extended family.

Trainer Notes: Ask participants to consider the above case and questions for 3 minutes. Solicit answers from the groups. Add any other answers they may have overlooked. Answers: As per NACO guideline, single dose Nevirapine can be administered and the newborn given Nevirapine syrup. Other services she may need needed: Feeding options counselling. Family planning counselling. Provide contraceptive method (permanent/temporary + barrier methods). Regular follow up of the baby and the mother. HIV testing for baby at 18 months. Post-test counselling. Partner counselling and testing. Couples counselling. Social, economic, mental &amp; spiritual support to the couple and the extended family.

Trainer Notes: The trainer needs to discuss the points under the following heads: Question-1 Does this woman need ART? Answer-1 : she is eligible for ART because her CD4 cell count is less than 250. Question-2 How will you manage this pregnant woman? Answer-2 This woman needs ART because her CD4 count is only 176 AZT, 3TC and NVP. Ask the participant why NOT EFV; EFV is contra- indicated in the first trimester of pregnancy. It has a teratogenic potential. Before ART is initiated, Treatment preparedness counselling, thorough Clinical and Lab assessment are needed Question-3: If the woman is also suffering from Pulmonary TB, how will you manage? Answer-3: Discuss the following points- Drug interaction between Rifampicin and NVP The contraindication of EFV during first trimester of pregnancy Start ATT first and wait till the completion first trimester and then start ART with EFV The option of medical termination of pregnancy if the pregnancy is second or third and the first child is living

Prevention of Parent To Child Transmission PPTCT

1.
Prevention of Parent-to-Child Transmission (PPTCT)PPTCT Overview

2.
Session Objectives By the end of the session, the participants will be able to discuss: • Describe NACO’s four-pronged strategy for PPTCT • Understand the factors that influence PTCT • Understand interventions to reduce PTCT • Discuss measures to overcome PPTCT issues in a resource-restricted settingPPTCT Overview 2

4.
HIV and Women in India Indicator Number Number of women who are HIV infected 0.9 million (38%) in India and % of total Number of annual pregnancies in India 27 million Estimated number of HIV positive 43,000 pregnancies (2009)PPTCT Overview 4

5.
NACO’s 4-Pronged PPTCT Strategy • Primary prevention of HIV among women of childbearing age • Preventing unintended pregnancies among women living with HIV • Preventing HIV transmission from a woman living with HIV to her infant • Providing appropriate treatment, care and support to women living with HIV and their children and familiesPPTCT Overview 5

6.
Estimated Risk and Timing of PTCT in the Absence of Interventions Transmission Risk of HIV Transmission Rate During pregnancy 5-10% During labour and delivery 10-15% During breastfeeding 5-20% Overall without breastfeeding 15-25% Overall with breastfeeding to six months 20-35% Overall with breastfeeding to 18-24 months 30-45% Source: WHOPPTCT Overview 6

14.
Interventions During Labour and Delivery • Do not use suction unless absolutely necessary – If suction is a must, use either mechanical suction at <100 mm Hg pressure or bulb suction, rather than mouth-operated suction • Clamp cord after it stops pulsating and after giving the mother oxytocin • For all infants: – When head is delivered wipe infant’s face with gauze or cloth – After infant is completely delivered, thoroughly wipe dry with a towel and transfer to the motherPPTCT Overview 14

15.
Considerations Regarding Mode of Delivery • Caesarean section performed before the onset of labour or membrane rupture has been associated with reduced HIV Transmission from Mother to Child • The risk of elective Caesarean for PMTCT should be assessed carefully in the context of factors such as: – Risk of post-operative complications – Safety of the blood supply – Cost • In India, normal vaginal delivery is recommended unless the woman has obstetric reasons (like foetal distress, obstructed labour, etc) for a C-section • Use of ART can reduce risk of PTCT better and with less risk than a C-sectionPPTCT Overview 15

19.
Anti Retroviral prophylaxis and therapy • ARV prophylaxis: Short-term use of antiretroviral drugs to reduce HIV transmission from mother-to- infant • ARV therapy: Long-term use of antiretroviral drugs to treat maternal HIV and for PPTCT • ARVs during pregnancy decrease the HIV viral load in the mother’s blood, thus lowering the chance of her infant to get exposed to the virusPPTCT Overview 19

22.
ARV prophylaxis during Labour & Delivery for HIV-infected Women • Administer ARV therapy or ARV prophylaxis during labour according to national guidelines to reduce maternal viral load and provide protection to the infant • Avoid repeat dosing of single-dose NEVIRAPINE (e.g., in the case of false labour), as this can cause viral resistance – Ensure that a woman is in true labour before administering a single-dose of NVP – Document NVP administration clearly on a patient’s partogramme or medical record to avoid accidental repeat dosingPPTCT Overview 22

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Discussion Question What are the challenges of using single dose Nevirapine for prophylaxis ?PPTCT Overview 23

25.
First line Regimens for Pregnant Women Eligible for ART • AZT/3TC/NVP is the preferred regimen • Stavudine to be given in the place of Zidovudine in those having low haemoglobin (<9G%) • Women with contraindications to NVP (hepatotoxicity and rash) can be given EFV • Avoid Efavirenz during First Trimester of Pregnancy (teratogenic in first trimester) • Efavirenz to be used with caution and with “thorough” counselling of the risks to foetusPPTCT Overview 25

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Discussion question Can we give NVP based ART to a woman who has had single dose-NVP for PPTCT? NACO ART guidelines 2007; CID 2008; 46: 622-4.PPTCT Overview 26

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NACO’s Key Principles (1) • ART is only one component of PPTCT • Selection of ART is based on: • Effective regimen available for treatment of maternal disease • Teratogenic potential of the drugs should pregnancy occur • Provide ART to pregnant women based on national guidelinesPPTCT Overview 27

28.
NACO’s Key Principles (2) • Offer pregnant women the most efficacious PPTCT regimens • Simple and effective regimens should be used in order to expand coverage and benefit more people • Simple ARV with NVP should be considered as short term alternative until changes in national health system takes placePPTCT Overview 28

30.
Case Study 2 An unregistered primagravida patient: – Admitted with labour pains for 2 hours – Rapid test for HIV is positive 1. What ARV regimen is appropriate for this patient? 2. What other services will this patient need?PPTCT Overview 30

31.
Case Study 3 A pregnant woman, in the first trimester, comes with CD4 cell count of 176 1. Does this woman need ART? 2. How will you manage this pregnant woman? 3. If the woman is also suffering from pulmonary TB, how will you manage?PPTCT Overview 31

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Challenges to Implementing Interventions to Prevent PTCT • A significant proportion of deliveries continue to be unsupervised Home deliveries in many states • Many of the hospital deliveries still remain uncovered by PPTCT for different reasons • Most of the private institutional deliveries are not covered by PPTCT • Gaps in initiating early ART for the eligible HIV positive pregnant mothers • Infant feeding practices / options for HIV exposed infants: varied perceptions, opinions and advicesPPTCT Overview 32